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Background & Aims

In women with inflammatory bowel disease (IBD), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns.

Methods

We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 to 2016. Serum samples collected from infants at least 7 months old of were analyzed for titers of antibodies to Haemophilus influenzae B (HiB) or tetanus toxin; mothers completed a survey of vaccine practices and outcomes from July 2013 through October 2016. Umbilical cord blood samples from 33 infants were assayed for concentration of biologic agents. Vaccination response was compared between infants born to mothers exposed to biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, natalizumab, vedolizumab, or ustekinumab -- either as a single agent or in combination with an immunomodulator at any time between conception and delivery) and infants born to unexposed mothers.

Results

A total of 179 women completed the vaccine survey (26 biologic unexposed, 153 biologic exposed). We found no significant difference in proportions of infants with protective antibody titers against Hib born to exposed mothers (n=42) (71%) versus unexposed mothers (n=8) (50%) (P=.41). We also found no difference in the proportion of infants with protective antibody titers to tetanus toxoid born to exposed mothers (80%) versus unexposed mothers (75%) (P=.66). The median concentration of infliximab in cord blood did not differ significantly between infants with versus without protective antibody titers to HiB (P=.30) or tetanus toxoid (P=.93). Mild reactions were observed in seven of 40 infants who received rotavirus vaccine and whose mothers had been exposed to biologic therapies.

Conclusions

Vaccination of infants against HiB and tetanus toxin, based on antibody titers measured after 7 months of age, does not appear to be affected by in utero exposure to biologic therapy.

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Use of Biologic Therapy by Pregnant Women with Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines

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